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Randomized Controlled Trial
. 2024 Jan;47(1):36-44.
doi: 10.1007/s00270-023-03536-5. Epub 2023 Nov 27.

A Prospective Multicenter Randomized Controlled Trial for Comparing Drug-Coated and Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Arteriovenous Grafts

Dong Erk Goo  1 , Yong Jae Kim  2 , Sang Woo Park  3 , Ho Jong Cheon  4 , You Dong Won  5 , Seung Boo Yang  6
Affiliations
Randomized Controlled Trial

A Prospective Multicenter Randomized Controlled Trial for Comparing Drug-Coated and Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Arteriovenous Grafts

Dong Erk Goo et al. Cardiovasc Intervent Radiol. 2024 Jan.

Abstract

Purpose: To evaluate the efficacy and safety of drug-coated balloon angioplasty compared to conventional balloon angioplasty in the treatment of dysfunctional arteriovenous grafts.

Materials and methods: This prospective, multicenter, randomized clinical trial enrolled 190 patients with venous anastomotic stenosis in arteriovenous grafts at five participating hospitals. During pre-dilation, 4 patients dropped out due to ruptures requiring further treatment (n = 2) and residual stenosis of > 30% (n = 2). On successful pre-dilation with a 7 mm conventional balloon, patients were randomized to undergo either a 7 mm drug-coated balloon (n = 94) or conventional balloon angioplasty (n = 92). The primary out-come measure was target lesion primary patency at 3 and 6 months. The secondary out-come measures included target lesion primary patency at 12 months and access circuit primary patency at 6 and 12 months, clinical and technical success rates, and 12-month mortality differences between the groups.

Results: The target lesion primary patency and access circuit patency rates at 3 and 6 months were significantly higher in drug-coated balloon angioplasty group as compared to conventional balloon angioplasty group. The technical and clinical success rates were 100% for both the groups. As a procedure-related complication, anastomotic site rupture occurred during pre-dilation in 4 cases. The number of deaths during the 12-month follow-up was one for each group. The number of early thrombotic events (at < 3 months) was significantly higher in the drug-coated balloon group (p = 0.002).

Conclusion: Drug-coated balloon angioplasty was more effective and safer for the treatment of dysfunctional arteriovenous grafts compared to conventional balloon angioplasty.

Keywords: Arteriovenous grafts; Conventional balloon angioplasty; Drug-coated balloon angioplasty; Randomized controlled trial; Venous anastomotic stenosis.

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